FDA 510(k)

ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE

N.º K: K163370 · 2017-05-05

Fecha de decisión2017-05-05

Código de productoDHB

Comité asesorIM

DecisiónSubstantially Equivalent

Resumen del dispositivo

ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE is the device name listed in this FDA 510(k) record. The listed applicant is Phadia AB. It received FDA 510(k) clearance on 2017-05-05 under 510(k) number K163370. The device is classified under product code DHB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE?

ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE is a medical device that received FDA 510(k) clearance on 2017-05-05. The listed applicant is Phadia AB. The 510(k) number is K163370.

When did ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE receive FDA 510(k) clearance?

ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE received FDA 510(k) clearance on 2017-05-05, under 510(k) number K163370.

Who is the listed applicant for ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE?

The FDA 510(k) record lists Phadia AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE?

The FDA product code for ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE is DHB.

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Otros registros que enlistan a Phadia AB como solicitante

K253367EliA CTD 13 Screen K212181ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed K210902EliA Ro52, EliA Ro60 K202540EliA Rib-P K202541EliA RNA Pol III K202067EliA SmDP-S

Ver todos los 23 dispositivos →

Dispositivos relacionados (Código: DHB)

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Fuente oficial

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